The Senior Engineering Manager is a strategic and hands-on leader responsible for setting direction and developing a team of Manufacturing Engineers (MEs) and Quality Engineers (QEs) to support safe, compliant, and efficient production in a regulated manufacturing environment. This role provides technical, people, and organizational leadership across manufacturing processes,

inspection strategy, and continuous improvement while ensuring alignment with business objectives, customer requirements, and regulatory standards.

Passion

Essential Job Functions:

• Passion:
• People & Technical Leadership Lead and develop Manufacturing and Quality Engineers to build strong technical capability, accountability, and engagement. Foster a culture of ownership and continuous learning while strengthening technical depth, decision-making rigor, and succession readiness.
• Operational & Business Excellence Champion engineering and quality excellence through disciplined execution, robust processes, and proactive risk management. Ensure engineering resources are effectively aligned to support production, NPI, CapEx, and strategic initiatives.
• Trustworthiness:
• Quality Leadership Ensure manufacturing and quality engineering activities comply with applicable regulatory and quality system requirements (e.g., ISO 13485, FDA QSR, GxP). Serve as a trusted leader for audits, inspections, and customer quality engagements
• Continuous Improvement & Risk Management Partner cross-functionally to deliver responsive, data-driven engineering and quality support. Serve as the escalation point for complex process, quality, and customer issues, ensuring disciplined change management to protect quality and delivery.
• Drive Results:
• Problem Solving & Corrective Action Lead and support root cause investigations, CAPAs, and continuous improvement initiatives to eliminate defects, reduce variation, and prevent recurrence.
• Project & Resource Management Prioritize and balance engineering and quality workloads to support production needs, NPI, and strategic initiatives.
• Collaboration:
• Cross-Functional Partnership Align engineering and quality efforts with site and company objectives through strong cross-functional partnership. Lead engineering and quality execution for NPI, ensuring manufacturability, robust validation, and scalable inspection strategies.
  

Skills

• Strong people leadership and coaching capabilities
• Deep technical expertise in machining-intensive manufacturing environments (CNC turning, Swiss lathes, CNC grinding, secondary operations) and quality inspection
• Expertise in root cause analysis, CAPA, PFMEA, control plans, and validation
• Strong project management, prioritization, and decision-making skills
• Ability to interpret data, manage risk, and drive fact-based decisions
• Excellent communication skills; ability to influence across levels and functions
  
  

Experience

• 8-12+ years of experience in machining-focused manufacturing engineering within a regulated or high-precision environment (medical device, aerospace, automotive, or similar preferred)
• 5+ years of people leadership or technical team leadership experience
• Demonstrated hands-on experience with CNC machining processes, including process development, troubleshooting, and production support
• Experience with regulated manufacturing environment and quality systems such as ISO 13485 or FDA QSR, GxP, validation protocols, and audit readiness
  
  

Education

• Education: Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or related technical field.
• Licenses/Certification: Certifications such as Six Sigma, Lean Manufacturing, or ASQ credentials preferred.
• Technology/Equipment: Microsoft Office Applications and familiarity with manufacturing software systems (MES, ERP, process monitoring tools)
  
  

Physical Demands

• Ability to work in both office and manufacturing environments for extended periods
• Occasional lifting and/or moving of up to 20 lbs. (fixtures, tooling, small equipment)
• Must be able to wear Personal Protective Equipment (PPE) as required in manufacturing areas.
• Excellent visual acuity for inspection, reading drawings, and reviewing documentation.
• Ability to hear and communicate clearly in meetings, on calls, and during team discussions.
  
  

Working Conditions

• Primarily office-based with regular time spent on the production floor and in controlled manufacturing environments.
• Standard Monday–Friday schedule, with flexibility to support production needs or project milestones.
• Frequent interaction with manufacturing equipment, processes, and cross-functional teams
  
  

Reporting Structure

This position reports to the Director of Engineering